AzTrials
AzTrials

Endometrial NeoplasmsPhase 3NCT04634877

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

A Phase 3 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 231 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
990 participants
Where
231 sitesin 28 countries
Study dates
10 Jan 2021to 20 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
  • Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
  • Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
  • Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
  • Has not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
  • Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.
  • Has adequate organ function within 7 days of randomization.

Who cannot join

  • Has recurrent endometrial carcinoma or carcinosarcoma.
  • Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
  • Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation.
  • Is known to have a deoxyribonucleic acid (DNA) polymerase epsilon catalytic subunit A (POLE) mutation.
  • Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery.
  • Has residual tumor whether measurable or non-measurable after surgery.
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  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
  • Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
  • Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
  • Has received a live vaccine within 30 days before the first dose of study intervention.
  • Note: killed vaccines are allowed.
  • Has a known intolerance to study intervention (or any of the excipients).
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
  • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Has any contraindication to the use of carboplatin or paclitaxel.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of HIV infection.
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Has had an allogenic tissue/solid organ transplant.
  • Has not recovered adequately from surgery and/or any complications from the surgery.
  • Is breastfeeding.

Trial locations and contacts

231 sites in 28 countries.

231 sites in 28 countries

United States29 sites

  • Northside Hospital ( Site 3036)

    Atlanta, Georgia, 30342

  • University Of Colorado ( Site 3051)

    Aurora, Colorado, 80045

  • University of Alabama - Birmingham ( Site 3061)

    Birmingham, Alabama, 35249

  • Northwestern Memorial Hospital ( Site 3044)

    Chicago, Illinois, 60611

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3066)

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center ( Site 3063)

    Dallas, Texas, 75390

  • Duke Cancer Center ( Site 3072)

    Durham, North Carolina, 27710

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)

    Fargo, North Dakota, 58102

  • Parkview Cancer Institute ( Site 3067)

    Fort Wayne, Indiana, 46845

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital and Clinics ( Site 3046)

    Iowa City, Iowa, 52242

  • UCSD Moores Cancer Center ( Site 3053)

    La Jolla, California, 92093-0698

  • Norton Cancer Institute - St. Matthews ( Site 3056)

    Louisville, Kentucky, 40207

  • Mount Sinai Cancer Center ( Site 3081)

    Miami Beach, Florida, 33140

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)

    Mineola, New York, 11501

  • University of South Alabama, Mitchell Cancer Institute ( Site 3058)

    Mobile, Alabama, 36604

  • Smilow Cancer Hospital at Yale New Haven ( Site 3070)

    New Haven, Connecticut, 06511

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)

    New York, New York, 10016

  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)

    Philadelphia, Pennsylvania, 19107

  • HonorHealth Research Institute - Biltmore ( Site 3043)

    Phoenix, Arizona, 85016

  • AHN West Penn Hospital ( Site 3060)

    Pittsburgh, Pennsylvania, 15224

  • Legacy Good Samaritan Medical Center ( Site 3033)

    Portland, Oregon, 97210

  • VCU Massey Cancer Center ( Site 3068)

    Richmond, Virginia, 23298

  • WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)

    Shreveport, Louisiana, 71103

  • Sanford Gynecology Oncology ( Site 3045)

    Sioux Falls, South Dakota, 57104

  • Montefiore Medical Center ( Site 3065)

    The Bronx, New York, 10461

  • Arizona Oncology Associates PC- HOPE ( Site 3049)

    Tucson, Arizona, 85711

  • Abington Hospital - Asplundh Cancer Center ( Site 3073)

    Willow Grove, Pennsylvania, 19090

  • University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 3037)

    Worcester, Massachusetts, 01605

Other trials in United States

China24 sites

  • Beijing Cancer Hospital ( Site 4048)

    Beijing, Beijing Municipality, 100036

  • Peking Union Medical College Hospital ( Site 4036)

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University ( Site 4057)

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital ( Site 4050)

    Changsha, Hunan, 410006

  • Xiangya Hospital Central South University ( Site 4035)

    Changsha, Hunan, 410008

  • Sichuan Cancer Hospital. ( Site 4039)

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital ( Site 4040)

    Chongqing, Chongqing Municipality, 400030

  • The First Affiliated Hospital ( Site 4043)

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)

    Hangzhou, Zhejiang, 310003

  • Women s Hospital School of Medicine Zhejiang University ( Site 4032)

    Hangzhou, Zhejiang, 310006

  • Harbin Medical University Cancer Hospital ( Site 4033)

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)

    Hefei, Anhui, 230001

  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)

    Kunming, Yunnan, 650107

  • Jiangxi Maternal and Child Health Hospital ( Site 4051)

    Nanchang, Jiangxi, 530021

  • Nanjing Drum Tower Hospital ( Site 4037)

    Nanjing, Jiangsu, 210008

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)

    Nanning, Guangxi, 530221

  • Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)

    Shanghai, Shanghai Municipality, 200090

  • Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)

    Shanghai, Shanghai Municipality, 200127

  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)

    Shanghai, Shanghai Municipality, 201204

  • Tianjin Medical University Cancer Institute & Hospital ( Site 4054)

    Tianjin, Tianjin Municipality, 300000

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)

    Wenzhou, Zhejiang, 325000

  • Hubei Cancer Hospital ( Site 4059)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University ( Site 4060)

    Xiamen, Fujian, 361003

Other trials in China

Japan17 sites

  • Hyogo Cancer Center ( Site 4195)

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Kyushu Cancer Center ( Site 4193)

    Fukuoka, 811-1395

  • University of the Ryukyus Hospital ( Site 4184)

    Ginowan, Okinawa, 901-2725

  • Saitama Medical University International Medical Center ( Site 4182)

    Hidaka, Saitama, 350-1298

  • National Cancer Center Hospital East ( Site 4197)

    Kashiwa, Chiba, 277-8577

  • Kurume University Hospital ( Site 4186)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 4181)

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center ( Site 4190)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 4185)

    Niigata, 951-8566

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 4188)

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center ( Site 4183)

    Ōta, Gunma, 373-8550

  • Hokkaido University Hospital ( Site 4194)

    Sapporo, Hokkaido, 060-8648

  • Iwate Medical University Hospital ( Site 4189)

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center ( Site 4192)

    Suntogun, Shizuoka, 411-8777

  • Cancer Institute Hospital of JFCR ( Site 4196)

    Tokyo, 135-8550

  • Keio University Hospital ( Site 4191)

    Tokyo, 160-8582

  • Ehime University Hospital ( Site 4187)

    Tōon, Ehime, 791-0295

Other trials in Japan

Russia13 sites

  • Arkhangelsk Clinical Oncological Dispensary ( Site 2637)

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 2646)

    Kazan', Tatarstan, Respublika, 420029

  • Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF Dep.of antitumor drug therapy #4 ( Site 2634)

    Moscow, Moscow, 115522

  • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)

    Moscow, Moscow, 125284

  • Scientific Research Institute of Clinical Oncology "Nizhegorodsky Regional Oncology Dospensary" ( Site 2639)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)

    Samara, Samara Oblast, 443031

  • National Research Ogarev Mordovia State University ( Site 2648)

    Saransk, Mordoviya, Respublika, 430032

  • Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)

    Tomsk, Tomsk Oblast, 634028

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)

    Ufa, Baskortostan, Respublika, 450054

  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

France12 sites

  • CHU Besancon - Hopital Jean Minjoz ( Site 2068)

    Besançon, Doubs, 25000

  • Institut Bergonie ( Site 2067)

    Bordeaux, Gironde, 33076

  • Centre Francois Baclesse ( Site 2062)

    Caen, Calvados, 14076

  • Institut Regional du Cancer de Montpellier - ICM ( Site 2069)

    Montpellier, Herault, 34298

  • Hopital prive du Confluent ( Site 2061)

    Nantes, Loire-Atlantique, 44277

  • Centre Antoine Lacassagne ( Site 2073)

    Nice, Alpes-Maritimes, 06189

  • Hopital Cochin ( Site 2070)

    Paris, Île-de-France Region, 75014

  • Centre Hospitalier Lyon Sud ( Site 2064)

    Pierre-Bénite, Rhone, 69310

  • Hôpital Privé Des Côtes d'Armor ( Site 2063)

    Plérin, Cotes-d Armor, 22190

  • Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)

    Toulouse, Haute-Garonne, 31059

  • Institut De Cancerologie De Lorraine ( Site 2072)

    Vandœuvre-lès-Nancy, Ain, 54519

  • Gustave Roussy ( Site 2071)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Belgium11 sites

  • AZORG Campus Aalst-Moorselbaan ( Site 2038)

    Aalst, Oost-Vlaanderen, 9300

  • Saint-Luc UCL ( Site 2042)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • AZ Maria Middelares Gent ( Site 2032)

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Gent ( Site 2037)

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge ( Site 2036)

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven ( Site 2040)

    Leuven, Vlaams-Brabant, 3000

  • CHC - Groupe Sante ( Site 2041)

    Liège, 4000

  • CHU Liege Sart-Tilman ( Site 2044)

    Liège, 4000

  • C.I.U. Hopital Ambroise Pare ( Site 2039)

    Mons, Hainaut, 7000

  • AZ Nikolaas ( Site 2031)

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • CHR Verviers ( Site 2035)

    Verviers, Liege, 4800

Other trials in Belgium

Italy10 sites

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)

    Brescia, 25123

  • INOC - Istituto Nazionale Oncologico Candiolo ( Site 2125)

    Candiolo, Piedmont, 10060

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)

    Milan, Lombardy, 20133

  • IRCCS Ospedale San Raffaele ( Site 2130)

    Milan, 20132

  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)

    Milan, 20141

  • Azienda Ospedaliera Universitaria Federico II ( Site 2123)

    Naples, 80131

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)

    Padova, 35128

  • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)

    Roma, Abruzzo, 00144

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)

    Rome, Lazio, 00168

Other trials in Italy

Argentina9 sites

  • Centro de Oncología e Investigación de Buenos Aires ( Site 1005)

    Berazategui, Buenos Aires, B1884BBF

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)

    Buenos Aires, C1012AAR

  • Hospital Aleman ( Site 1001)

    Buenos Aires, C1118AAT

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)

    CABA, Buenos Aires, C1012AAR

  • CEMIC ( Site 1009)

    CABA, Buenos Aires, C1431FWO

  • Hospital Britanico de Buenos Aires ( Site 1002)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Centro Oncologico Riojano Integral ( Site 1007)

    La Rioja, F5300COE

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto de Oncologia de Rosario ( Site 1004)

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Germany8 sites

  • Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 2104)

    Dresden, Saxony, 01307

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)

    Essen, North Rhine-Westphalia, 45136

  • Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)

    Hanover, Lower Saxony, 30625

  • SLK-Kliniken Heilbronn GmbH ( Site 2116)

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitätsklinikum Schleswig-Holstein ( Site 2101)

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum Ludwigsburg ( Site 2111)

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Universitaetsklinikum Tuebingen ( Site 2113)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

United Kingdom8 sites

  • Bristol Haematology and Oncology Centre ( Site 2244)

    Bristol, Bristol, City of, BS2 8ED

  • Castle Hill Hospital-Academic Oncology ( Site 2252)

    Cottingham, East Riding Of Yorkshire, HU165JQ

  • Beatson West of Scotland Cancer Centre ( Site 2247)

    Glasgow, Glasgow City, G12 0YN

  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)

    Leicester, LE1 5WW

  • UCLH NHS Foundation Trust ( Site 2242)

    London, London, City of, NW1 2PG

  • Royal Marsden NHS Foundation Trust ( Site 2248)

    London, London, City of, SW3 6JJ

  • The Christie Hospital NHS Foundation Trust ( Site 2243)

    Manchester, M20 4BX

  • Royal Marsden Hospital Sutton-Surrey ( Site 2241)

    Sutton, London, City of, SM2 5PT

Other trials in United Kingdom

Mexico7 sites

  • Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)

    La Paz, Baja California Sur, 23040

  • Centro Oncologico Internacional. SEDNA ( Site 1121)

    Mexico City, Mexico City, 04700

  • Instituto Nacional de Cancerologia ( Site 1124)

    Mexico City, Mexico City, 14080

  • Hospital Angeles Roma ( Site 1123)

    Mexico City, 06700

  • Filios Alta Medicina ( Site 1125)

    Monterrey, Nuevo León, 64460

  • I Can Oncology Center SA de CV ( Site 1126)

    Monterrey, Nuevo León, 64710

  • Hospital San Lucas Cardiologica del Sureste ( Site 1122)

    Tuxtla Gutiérrez, Chiapas, 29090

Other trials in Mexico

Poland7 sites

  • Bialostockie Centrum Onkologii ( Site 2483)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)

    Gliwice, Silesian Voivodeship, 44-102

  • Swietokrzyskie Centrum Onkologii. ( Site 2485)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 2486)

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)

    Poznan, Greater Poland Voivodeship, 61-866

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)

    Siedlce, Masovian Voivodeship, 08-110

  • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)

    Warsaw, Masovian Voivodeship, 00-315

Other trials in Poland

Spain7 sites

  • Hospital Vall D Hebron ( Site 2182)

    Barcelona, 08035

  • Hospital Clinic i Provincial ( Site 2185)

    Barcelona, 08036

  • Hospital Universitario Reina Sofia ( Site 2183)

    Córdoba, 14004

  • Institut Català d'Oncologia (ICO) - Girona ( Site 2184)

    Girona, Gerona, 17007

  • Clinica Universitaria de Navarra ( Site 2181)

    Madrid, Madrid, Comunidad de, 28027

  • Hospital Clinico San Carlos ( Site 2187)

    Madrid, 28040

  • Hospital Universitario La Paz ( Site 2186)

    Madrid, 28046

Other trials in Spain

Turkey (Türkiye)7 sites

  • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)

    Adana, 01250

  • Cukurova Uni. Tip Fakultesi ( Site 2353)

    Adana, 01330

  • Baskent Universitesi Ankara Hastanesi ( Site 2354)

    Ankara, 06490

  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)

    Ankara, 06590

  • Medipol Universite Hastanesi ( Site 2352)

    Istanbul, 34214

  • Ege University Medical Faculty ( Site 2351)

    Izmir, 35100

  • I.E.U. Medical Point Hastanesi ( Site 2356)

    Izmir, 35575

Other trials in Turkey (Türkiye)

Ukraine7 sites

  • Chernihiv Medical Center of Modern Oncology ( Site 2368)

    Chernihiv, Chernihiv Oblast, 14029

  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)

    Chernivtsi, Chernivetska Oblast, 58013

  • SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)

    Kharkiv, Kharkiv Oblast, 61024

  • MNE "Khmelnytskyi regional antitumor center" ( Site 2365)

    Khmelnitskyi, Khmelnytskyi Oblast, 29009

  • LISOD - Israeli Oncological Hospital MedX-ray International Group LLC ( Site 2364)

    Kiev, Kyivska Oblast, 08720

  • Volyn Regional Clinical Hospital Regional Medical Oncology Centre ( Site 2362)

    Lutsk, Volyn Oblast, 43018

  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2361)

    Lviv, Lviv Oblast, 79031

Other trials in Ukraine

Greece6 sites

  • Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)

    Athens, Attica, 115 28

  • Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)

    Athens, Attica, 115 28

  • Athens University Hospital ATTIKON ( Site 2424)

    Chaïdári, Attica, 124 62

  • Hospital Hygeia ( Site 2426)

    Marousi, Attica, 151 23

  • General Hospital of Patras. St Andrews ( Site 2421)

    Pátrai, Achaia, 263 35

  • Euromedica General Clinic of Thessaloniki ( Site 2422)

    Thessaloniki, 546 45

Other trials in Greece

Canada5 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 3007)

    Calgary, Alberta, T2N 5G2

  • Kingston Health Sciences Centre ( Site 3003)

    Kingston, Ontario, K7L 2V7

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)

    Montreal, Quebec, H2X 0C1

  • McGill University Health Centre ( Site 3005)

    Montreal, Quebec, H4A 3J1

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3002)

    Québec, Quebec, G1J 1Z4

Other trials in Canada

Chile5 sites

  • Fundacion Arturo Lopez Perez FALP ( Site 1062)

    Santiago, Region M. de Santiago, 7500921

  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

    Santiago, Region M. de Santiago, 8330032

  • Bradfordhill-Clinical Area ( Site 1070)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigación del Cáncer James Lind ( Site 1061)

    Temuco, Araucania, 4800827

  • Oncocentro ( Site 1065)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Denmark5 sites

  • Aalborg Universitetshospital ( Site 2511)

    Aalborg, North Denmark, 9100

  • Rigshospitalet University Hospital ( Site 2515)

    Copehagen, Capital Region, 2100

  • Herlev Hospital ( Site 2514)

    Herlev, Capital Region, 2730

  • Odense Universitetshospital ( Site 2512)

    Odense, Region Syddanmark, 5000

  • Roskilde Sygehus ( Site 2513)

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Israel5 sites

  • Rambam Medical Center ( Site 2307)

    Haifa, 3525408

  • Edith Wolfson Medical Center ( Site 2306)

    Holon, 5810001

  • Hadassah Medical Center. Ein Kerem ( Site 2303)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 2305)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 2301)

    Ramat Gan, 5265601

Other trials in Israel

South Korea5 sites

  • National Cancer Center ( Site 4065)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Bundang Hospital ( Site 4063)

    Seongnam-si, Kyonggi-do, 13620

  • Severance Hospital Yonsei University Health System ( Site 4062)

    Seoul, 03722

  • Asan Medical Center ( Site 4061)

    Seoul, 05505

  • Samsung Medical Center ( Site 4064)

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • Changhua Christian Hospital ( Site 4095)

    Changhua, 50006

  • Taichung Veterans General Hospital ( Site 4094)

    Taichung, 407

  • MacKay Memorial Hospital ( Site 4092)

    Taipei, 10449

  • Taipei Veterans General Hospital ( Site 4093)

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital ( Site 4091)

    Taoyuan, 33305

Other trials in Taiwan

Colombia4 sites

  • Instituto Nacional de Cancerología E.S.E ( Site 1094)

    Bogotá, Bogota D.C., 111511

  • Fundación Valle del Lili ( Site 1093)

    Cali, Valle del Cauca Department, 760032

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1096)

    Medellín, Antioquia, 050030

  • Instituto Cancerologico de Nariño S.A.S. ( Site 1092)

    Pasto, Departamento de Nariño, 520002

Other trials in Colombia

Czechia4 sites

  • Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)

    Brno, Brno-mesto, 62500

  • Fakultni nemocnice Olomouc ( Site 2392)

    Olomouc, 77900

  • Fakultni nemocnice Kralovske Vinohrady ( Site 2393)

    Prague, Praha 10, 100 34

  • Vseobecna fakultni nemocnice v Praze ( Site 2391)

    Prague, Praha 2, 128 08

Other trials in Czechia

Finland3 sites

  • Kuopio University Hospital ( Site 2543)

    Kuopio, Northern Savonia, 70210

  • Tampere University Hospital ( Site 2541)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital ( Site 2542)

    Turku, Southwest Finland, 20520

Other trials in Finland

Norway3 sites

  • Soerlandet sykehus HF Kristiansand ( Site 2152)

    Kristiansand, Vest-Agder, 4615

  • Oslo Universitetssykehus Radiumhospitalet ( Site 2151)

    Oslo, 0310

  • University Hospital of North Norway ( Site 2153)

    Tromsø, Troms, 9019

Other trials in Norway

Sweden3 sites

  • Universitetssjukhuset i Linkoping. ( Site 2222)

    Linköping, Östergötland County, 581 85

  • Karolinska Universitetssjukhuset Solna ( Site 2220)

    Solna, Stockholm County, 171 76

  • Blod-och Tumorsjukdomar ( Site 2221)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Austria2 sites

  • Medizinische Universitat Graz ( Site 2004)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck ( Site 2001)

    Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

Being tested
Pembrolizumab, Carboplatin, Paclitaxel, Placebo for pembrolizumab, Docetaxel
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2 )
Medical subject headings
Endometrial Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    IV infusion

  • CarboplatinDrug

    IV infusion

  • PaclitaxelDrug

    IV infusion

  • Placebo for pembrolizumabDrug

    IV infusion

  • DocetaxelDrug

    IV infusion docetaxel 75 mg/m^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.

  • CisplatinDrug

    Also called Platinol®, Platinol®-AQ

    Cisplatin 75 mg/m^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.

  • External Beam Radiotherapy (EBRT)Radiation

    ≥4500 cGY given according to local practice, at the discretion of the investigator

  • Cisplatin (as radiosensitizer)Drug

    Also called Platinol®, Platinol®-AQ

    If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29

  • BrachytherapyRadiation

    Also called Internal radiation therapy

    Given according to local practice, at the discretion of the investigator

Study groups in NCT04634877
Study groupRoleWhat they receive
Pembrolizumab + ChemotherapyExperimentalParticipants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Docetaxel; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Drug: Cisplatin (as radiosensitizer); Radiation: Brachytherapy
Placebo + ChemotherapyPlacebo comparatorParticipants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo for pembrolizumab; Drug: Docetaxel; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Drug: Cisplatin (as radiosensitizer); Radiation: Brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence

    DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.

    Measured: Up to approximately 42 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 54 months

Secondary outcomes (10)

  1. Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence

    DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by BICR or by histopathologic confirmation of suspected disease recurrence, will be presented.

    Measured: Up to approximately 42 months

  2. Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status

    DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.

    Measured: Up to approximately 42 months

  3. Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status

    OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.

    Measured: Up to approximately 54 months

  4. Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status

    DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status, will be presented.

    Measured: Up to approximately 42 months

  5. Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status

    OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status will be presented.

    Measured: Up to approximately 54 months

  6. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.

    Measured: Up to approximately 54 months

  7. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 52 weeks

  8. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score

    The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.

    Measured: Baseline and up to approximately 54 months

  9. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.

    Measured: Baseline and up to approximately 54 months

  10. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score

    The EORTC-QLQ-EN24 is a 24-item questionnaire developed to be used in conjunction with the EORTC-QLQ-C30 to assess the quality of life of endometrial cancer patients. Participant responses are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in EORTC QLQ-E24 score will be presented.

    Measured: Baseline and up to approximately 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start10 Jan 2021
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion20 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
990 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634877
Sponsor's protocol ID
3475-B21
Other IDs
KEYNOTE-B21, ENGOT-en11, GOG-3053, jRCT2031200399, 2022-501973-37-00, U1111-1282-6430, 2020-003424-17
Status last verified
Sep 2026
First submitted
12 Nov 2020
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Van Gorp T, Cibula D, Lv W, Backes F, Ortac F, Hasegawa K, Lindemann K, Savarese A, Laenen A, Kim YM, Bodnar L, Barretina-Ginesta MP, Gilbert L, Pothuri B, Chen X, Flores MB, Levy T, Colombo N, Papadimitriou C, Buchanan T, Hanker LC, Eminowicz G, Rob L, Black D, Lichfield J, Lin G, Orlowski R, Keefe S, Lortholary A, Slomovitz B; ENGOT-en11/GOG-3053/KEYNOTE-B21 investigators. ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. Ann Oncol. 2024 Nov;35(11):968-980. doi: 10.1016/j.annonc.2024.08.2242. Epub 2024 Sep 14.

    PubMed 39284383

  • Slomovitz BM, Cibula D, Lv W, Ortac F, Hietanen S, Backes F, Kikuchi A, Lorusso D, Danska-Bidzinska A, Samouelian V, Barretina-Ginesta MP, Vulsteke C, Lai CH, Pothuri B, Zhang Y, Magallanes-Maciel M, Amit A, Guarneri V, Zagouri F, Bell M, Welz J, Eminowicz G, Hruda M, Willmott LJ, Lichfield J, Wang W, Orlowski R, Aktan G, Gladieff L, Van Gorp T. Pembrolizumab or Placebo Plus Adjuvant Chemotherapy With or Without Radiotherapy for Newly Diagnosed, High-Risk Endometrial Cancer: Results in Mismatch Repair-Deficient Tumors. J Clin Oncol. 2025 Jan 20;43(3):251-259. doi: 10.1200/JCO-24-01887. Epub 2024 Oct 16.

    PubMed 39411812

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 231 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, China, Japan, Russia, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence (time frame: Up to approximately 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04634877, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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Clinical Trial NCT04634877 | AzTrials